Your browser does not support JavaScript! COMPLETE BEAUTY (OCTINOXATE, ZINC OXIDE) LOTION [WAKEFERN FOOD CORPORATION]
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COMPLETE BEAUTY (octinoxate, zinc oxide) lotion
[Wakefern Food Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Extra back panel claims

Complete

beauty lotion

all day moisturizer

Broad Sptctrum SPF 15

Sunscreen

ShopRite

Active ingredients

Active ingredients

Octinoxate 6.0%

Zinc Oxide 3.0%

Purpose

Purpose

Sunscreen

Use

Uses

  • helps prevent sunbrun
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

Warnings

For external use only

Do not use

Do not use on damaged or broken skin


When using this product

When using this product keep out of eyes. rinse with water to remove

Stop use

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures, spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protections measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-fleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

other information

Other information

  • protect the product from excessive heat and direct sun

Inactive ingredients

Inactive ingredients water, glycerin, isohexadecan, polysorbate 80, sodium acrylate/acryloyldimethyl taurate copolymer, laureth-7, cyclopentasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, gossypium herbaceum (cotton) seen oil, behenyl alcohol, tocopheryl acetate, cetyl alcohol, DMDM hydantoin, itodpropynyl butylcarbamate, steareth-2, disodium EDTA, aloe barbadensis leaf extract, oleth-3 phosphate

Side Panel Claims

Broad spectrum SPF 15

Sunscreen

with vitaming E and aloe

Sensitive Skin

light and non-greasy lotion

ShopRite

Disclaimer

This product is not manufactured or distributed by Procter + Gamble, distributer or Olay Complete All Day Moisture Lotion SPF 15

Adverse Reactions Section

DISTRIBUTED BY

WAKEFERN FOOD CORPORATION

5000 RIVERSIDE DRIVE,

KEASBEY, NJ O8832

1-800-SHOPRITE

www.shoprite.com

principal display panel

Compare to Olay Complete All Day Moisture Lotion SPF 15

complete

beauty

lotion

all day

moisturizer

Broad Spectrum SPF 15

Sunscreen

with vitamin E and aloe

Sensitive Skin

light and non-greasy lotion

ShopRite

4 FL OZ (118 mL)

image description

COMPLETE BEAUTY 
octinoxate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41190-503
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE60 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
ISOHEXADECANE 
POLYSORBATE 80 
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) 
LAURETH-7 
CYCLOMETHICONE 5 
PEG/PPG-20/20 DIMETHICONE 
STEARETH-21 
STEARYL ALCOHOL 
LEVANT COTTONSEED OIL 
DOCOSANOL 
.ALPHA.-TOCOPHEROL ACETATE 
CETYL ALCOHOL 
DMDM HYDANTOIN 
IODOPROPYNYL BUTYLCARBAMATE 
STEARETH-2 
EDETATE DISODIUM 
ALOE VERA LEAF 
OLETH-3 PHOSPHATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41190-503-261 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/09/2013
Labeler - Wakefern Food Corporation (069722418)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(41190-503)

Revised: 1/2013
 
Wakefern Food Corporation

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